An interventional study of Solsius SelfCare in Diabetic Foot Disease, Diabetic Foot Infection and Diabetic Foot Infections, sponsored by Solsius. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Solsius · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to evaluate the performance of a self-monitoring system (Solsius SelfCare) to detect pre-ulcerative clinical abnormalities in adults living with type 1 or 2 diabetes at high podiatric risk (grade 3 according to French HAS guidelines) and a history of healed diabetic foot wound.
The main question it aims to answer is:
- Can the Solsius SelfCare system detect pre-ulcerative foot abnormalities with a sensitivity of at least 80%, defined as the proportion of temperature threshold exceedances (≥ 2.2°C difference between symmetric plantar sites over 2 consecutive days) confirmed by a clinical abnormality identified by a podiatrist?
There is no comparison group. All participants will use the same device throughout the study.
Participants will:
Background
Diabetic foot ulcers affect approximately 18.6 million people worldwide each year and precede 80% of lower limb amputations in people living with diabetes. In France, an estimated 26,700 diabetic patients were hospitalized for a foot wound in 2016, and 8,400 underwent a lower limb amputation. Five-year mortality following a diabetic foot ulcer is estimated at 30.5%. Prevention of foot wounds in high-risk patients is therefore a major public health priority.
Skin temperature variations have been identified as an early warning signal for ulceration risk. A temperature difference greater than 2.2°C between symmetric plantar sites on the left and right foot has been associated with an increased risk of foot wound development. The 2023 International Working Group on the Diabetic Foot (IWGDF) guidelines recommend daily foot temperature monitoring in patients at moderate to high ulceration risk (IWGDF risk grades 2-3), with a clinical consultation advised if the 2.2°C threshold is exceeded on two consecutive days on the same side.
Solsius SAS has developed the Solsius SelfCare system, consisting of a pair of connected insoles embedding plantar temperature sensors and a paired smartphone application. The system automatically detects bilateral plantar temperature differentials and alerts the patient via push notification when the 2.2°C threshold is exceeded according to IWGDF criteria. The device is a CE-marked class I medical device under EU MDR 2017/745.
Study Design
DIAFOOTEM is a prospective, multicenter, single-blind performance evaluation study conducted at three French hospital centers (CHU Montpellier, CHU Lille, and Hôpital Saint-Vincent-de-Paul). The podiatrist assessor is blinded to the temperature data recorded by the device throughout the entire study, ensuring an objective and unbiased clinical evaluation.
Study Procedures
Patients follow their usual care routine and consult their podiatrist if the device detects an abnormal change in temperature.
At each visit, the podiatrist records the presence or absence of the following pre-ulcerative abnormalities on each foot.
Sample Size
A total of 60 patients will be enrolled across the three sites over a 12-month inclusion period, with a 12-month follow-up per patient (total study duration: 24 months).
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →This is the only study on the registry with Solsius as lead sponsor.
Compared within Diabetic Foot, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diabetic patients with stage 3 foot complications who wore Solsius SelfCare connected insoles for 12 months, in addition to their standard care
Device: Solsius SelfCare
Smart insoles incorporating plantar temperature sensors (bilateral measurement), worn daily whilst awake for 12 months. Push notification if the temperature difference between two symmetrical sites is ≥ 2.2°C for two consecutive days. Class I medical device, CE marked in accordance with MDR 2017/745.
To evaluate the performance of a self-monitoring system for detecting pre-ulcerative lesions in people living with stage 3 diabetic foot disease.
Sensitivity of the Solsius SelfCare system to detect pre-ulcerative clinical abnormalities confirmed by a podiatrist AND preceded by a temperature threshold exceedance (≥2.2°C between symmetrical foot sites on 2 consecutive days, at least once per day, on the same side). Sensitivity = VP / (VP + FN) × 100.
Time frame: 12 months
Assess specificity, positive predictive value (PPV), negative predictive value (NPV) and overall diagnostic accuracy
* Specificity, defined as the proportion of temperature exceedances not confirmed by a clinical abnormality (true negatives) among all non-events * Positive predictive value (PPV), defined as the probability that a temperature exceedance generated by the system actually corresponds to the presence of a clinical abnormality * Negative predictive value (NPV), defined as the probability that the absence of a temperature exceedance actually corresponds to the absence of a clinical abnormality * Overall diagnostic accuracy, defined as the proportion of correct classifications (true positives and true negatives) among all observed outliers
Time frame: 12 months
To compare the clinical decisions made by healthcare professionals following instances of elevated temperature identified by the Solsius SelfCare self-monitoring system
* Proportion of patients presenting a clinical abnormality verified by the diabetologist (the study's principal investigator), following a temperature exceedance (based on photographs taken by the podiatrist). * Proportion of agreement between the assessments made by the podiatrist and those made by the diabetologist. * Proportion of patients who experienced a temperature exceeding a threshold of 2.2°C, and who reported a cause via a self-administered questionnaire, without the presence of a clinical abnormality verified by the podiatrist.
Time frame: 12 months
Assess the temperature differentials measured via Solsius SelfCare
* Percentage of temperature exceedances of a 2.2°C threshold, justified according to the time elapsed between the exceedance of the threshold and the medical consultation: 24 hours - 48 hours - \> 48 hours * Percentage of temperature exceedances at the end of the study, according to the thresholds defined below: * \> 2.2°C * \> 2.75°C * \> 3.2°C * \> 3.75°C * Total number of occurrences of a temperature difference \> 2.2°C and average number per patient at the end of the study
Time frame: 12 months
Assessing the risk of developing a diabetic foot ulcer
Proportion of patients with a diabetic foot ulcer during the study follow-up period
Time frame: 12 months
Assess the care provided by the healthcare professional following a rise in temperature
Description of the care provided by the podiatrist (or the 'diabetic foot' nurse)
Time frame: 12 months
Assess the timeframe for a return to normal
Average time between exceeding the 2.2°C threshold and a return to normal
Time frame: 12 months
Assessing the frequency of podiatry appointments
\- Rate of podiatry visits, expressed as the number of visits per person-year of follow-up ;
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Number of days of insole use : Number of days on which the Solsius SelfCare insoles were worn during the monitoring period, recorded by the device. Unit: days. Time Frame: 12 months
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Mean daily insole wear time : Mean number of hours per day the insoles were worn, recorded by the device. Unit: hours/day. Time Frame: 6 and 12 months
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Mean daily step count : Mean number of steps per day recorded by the Solsius SelfCare insoles. Unit: steps/day. Time Frame: 12 months
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Adherence to insole use : Percentage of patients adherent to the insole wear protocol. Unit: % of participants. Time Frame: 12 months
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Adherence to self-monitoring : Percentage of patients adherent to the self-monitoring protocol. Unit: % of participants. Time Frame: 12 months
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
System Usability Scale (SUS) score : Usability assessed with the French version of the SUS. The score ranges from 0 to 100, and higher scores indicate better usability. Unit: score on a scale. Time Frame: last study visit (up to 12 months)
Time frame: 12 months
Assessing adverse events and effects
Number and nature of adverse events/serious adverse events attributable to the DMN (e.g.: injuries related to the insoles) during the follow-up period of the study.
Time frame: 12 months
Assessing defects
Number and nature of system faults (insoles, application) during the follow-up period of the study
Time frame: 12 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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